ELECSYS PSA (ON ELECSYS 1010)

K974189 · Boehringer Mannheim Corp. · LTJ · Jan 6, 1998 · Immunology

Device Facts

• Record ID: K974189
• Device Name: ELECSYS PSA (ON ELECSYS 1010)
• Applicant: Boehringer Mannheim Corp.
• Product Code: LTJ · Immunology
• Decision Date: Jan 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.6010
• Device Class: Class 2

Intended Use

Immunoassay for the in vitro quantitative determination of Prostate-Specific Antigen (PSA) in human serum and plasma to aid in the management of prostate cancer patients. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Boehringer Mannheim Elecsys 2010 and 1010 immunoassay analyzers.

Device Story

Elecsys PSA Assay is an electrochemiluminescence immunoassay (ECLIA) for quantitative PSA determination in human serum/plasma. Used on Elecsys 1010 immunoassay analyzers in clinical laboratory settings. Process: 40 µL sample incubated with biotinylated monoclonal PSA-specific antibody and ruthenium-labeled monoclonal PSA-specific antibody to form sandwich complex; streptavidin-coated microparticles added for solid-phase binding. Reaction mixture aspirated into measuring cell; microparticles magnetically captured on electrode surface; unbound substances removed via ProCell. Voltage application induces chemiluminescent emission measured by photomultiplier. Results calculated via instrument-specific calibration curve (2-point calibration + master curve from reagent bar code). Output aids clinicians in prostate cancer management through serial PSA monitoring.

Clinical Evidence

Bench testing only. Method comparison study (N=91) between Elecsys 1010 and Elecsys 2010 showed high correlation (Least Squares: y=0.9978x + 0.0040, r=0.9915; Passing Bablock: y=0.9825x + 0.0935, r=0.9915). Analytical performance: lower detection limit 0.006 ng/mL, functional sensitivity 0.07 ng/mL, linearity 0.01-100 ng/mL, and no hook effect up to 15,000 ng/mL.

Technological Characteristics

Electrochemiluminescence immunoassay (ECLIA). Sandwich principle using biotinylated and ruthenium-labeled monoclonal antibodies. Solid phase: streptavidin-coated microparticles. Detection: photomultiplier tube measuring chemiluminescent emission upon voltage application. Instrument: Elecsys 1010 (batch analyzer). Reagent storage: 20-25°C.

Indications for Use

Indicated for in vitro quantitative determination of PSA in human serum and plasma; intended for serial measurement of PSA to aid in the management of prostate cancer patients.

Regulatory Classification

Identification

A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.

Special Controls

*Classification.* Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.

Predicate Devices

• Elecsys PSA Assay on Elecsys 2010 (K964351/S1)

Submission Summary (Full Text)

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## 510(k) Summary

JAN = 6 1998

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page 25

#### PSA on Elecsys Elecsys® 1010

07/1180 According to the requirements of 21 CFR 807.92, the following information Introduction provides sufficient detail to understand the basis for a determination of substantial equivalence. Boehringer Mannheim Corporation 1. Submitter 4300 Hacienda Drive name, P.O. Box 9002 address, Pleasanton, CA 945660900 contact [phone] Contact Person: Patricia M. Klimley Date Prepared: November 6, 1997 Proprietary name: Elecsys® PSA Assay 2. Device name Common name: Electrochemiluminescence assay for the determination of Prostate-Specific Antigen (PSA). Classification name: System, Test, Prostate-Specific antigen We claim substantial equivalence to the Elecsys® PSA Assay on Elecsys 3. Predicate 2010. device The Elecsys® test principle is based on sandwich principle. Total duration of 4. Device assay: 18 minutes (37°C). Description ·1st incubation (9 minutes): Sample (40 µL), a biotinylated monoclonal PSAspecific antibody (60 uL), and a monoclonal PSA-specific antibody labeled with a ruthenium complex (60 uL) react to form a sandwich complex. ·2nd incubation (9 minutes): After addition of streptavidin-coated microparticles (40 uL), the entire complex is bound to the solid phase via interaction of biotin and streptavidin.

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# 510(k) Summary, Continued

.

.

| 4.<br>Device<br>Description | •The reaction mixture is aspirated into the measuring cell where the<br>microparticles are magnetically captured onto the surface of the electrode.<br>Unbound substances are then removed with ProCell. Application of a voltage<br>to the electrode then induces chemiluminescent emission which is measured<br>by a photomultiplier (0.4 second read frame).<br>•Results are determined via a calibration curve which is instrument-<br>specifically generated by 2-point calibration and a master curve provided via<br>the reagent bar code. | |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 5.<br>Intended use | Immunoassay for the in vitro quantitative determination of Prostate-Specific<br>Antigen in human serum and plasma to aid in the management of prostate<br>cancer patients. | |
| 6.<br>Comparison<br>to predicate<br>device | The Boehringer Mannheim Elecsys® PSA Assay has been approved for use<br>on the Elecsys 2010 immunoassay analyzer (K964351/S1). The application<br>of the Elecsys® PSA Assay on the Elecsys 1010 immunoassay analyzer is<br>substantially equivalent to the same assay (Elecsys PSA Assay) on the<br>Elecsys 2010. | |

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The following table compares the Elecsys® PSA on the Elecsys 1010 with the predicate device,Elecsys® PSA on the Elecsys 2010. Specific data on the performance of this test for both the Elecsys 1010 and 2010 have been incorporated into the draft labeling in attachment 5. Labeling for the predicate device provided in attachment 6 will be replaced upon the approval of this premarket approval submission with the combined Elecsys 2010 and 1010 insert (attachment 5).

### Similarities:

•Intended Use: Immunoassay for the in vitro quantitative determination of prostate-specific antigen. The assay is further indicated for serial measurement of PSA to aid in the management of cancer patients.

·Assay range: 0-100 ng/ml

· Assay methodology: Sandwich immunoassay

·Cross-Reactivity: 0% to PAP

·Kit (cat. no. 1731262) approved for use on the Elecsys 2010 (K964351/S1)

·Sample and reagent volumes

·Reaction temperature and incubation times

·Package insert

·Performance specifications

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# 510(k) Summary, Continued

Differences:

6. Comparison to predicate
device cont.

(

| Feature | Elecsys 1010 | Elecsys 2010 |
|--------------------------|--------------|---------------|
| Instrument required | Elecsys 1010 | Elecsys 2010 |
| Instrument System | Batch | Random access |
| Reagent Storage Temp (C) | 20-25C | 37C |

### Performance Characteristics:

| Feature | Elecsys 1010 | Elecsys 2010 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Lower<br>Detection Limit | 0.006 ng/mL<br>Functional: 0.07 ng/mL | 0.002 ng/mL<br>Functional: 0.03 ng/mL |
| Linearity | 0.01 - 100 ng/mL (with a<br>deviation from a linear line of<br>$\pm$ 10%) | 0.01 - 100 ng/mL (with a<br>deviation from a linear line of<br>$\pm$ 10%) |
| Method<br>Comparison | Vs Elecsys 2010<br><br>Least Squares<br>y=0.9978x + 0.0040<br>r=0.9915<br>N=91<br><br>Passing Bablock<br>y=0.9825x + 0.0935<br>r=0.9915<br>N=91 | Not shown |
| Hook Effect | No Hook Effect up to<br>15,000 ng/ml PSA | No Hook Effect up to<br>15,000 ng/ml PSA |

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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

JAN - 6 199

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Patricia M. Klimley Manager, Regulatory Affairs Boehringer Mannheim Corporation Laboratory Diagnostics 4300 Hacienda Drive Pleasanton, California 94566-0900

Re : K974189 Elecsys® PSA Assay Trade Name: Requlatory Class: II Product Code: LTJ Dated: November 6, 1997 Received: November 7, 1997

Dear Ms. Klimley:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) , it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the current Good Manufacturing Practice requirement, as set forth. in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. TO determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Putman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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12/22/97

11:09

510(k) Number (if known): N/A

Device Name: Elecsys® PSA Assay

Indications For Use:

Immunoassay for the in vitro quantitative determination of Prostate-Specific Antigen (PSA) in human serum and plasma. The Elecsys PSA assay is further indicated for serial measure of PSA to aid in the management of prostate cancer.

The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Bochringer Mannheim Elecsys 2010 and 1010 immunoassay analyzers.

Peter E. Maleni

(Division Sign-Off) Division of Chineal Laboratury Devices 510(k) Number -

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-The-Counter Use 6 (Per 21 CFR 801.109)

(Optional Format 1-2-96)

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